Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:12 PM
Ignite Modification Date:
2025-12-24 @ 7:12 PM
NCT ID:
NCT05595603
Eligibility Criteria:
Inclusion Criteria:
* patients with primary resectable GCT of bone
* lesion amenable to reconstruction (intralesional curettage) defined as having at least one intact column of bone after removal
* no previous systemic bisphosphonate or denosumab therapy
* with expected longer than 18 months of survival time
* sign the informed consent form
Exclusion Criteria:
* patients with recurrent GCT or extensive GCT which is impossible or inappropriate to use curettage surgery due to its "unresectable" nature.
* conduct unexpected surgery at other center
* the primary goal for surgery is revision
* patient conduct en-bloc/wide resection instead of curettage surgery
* patient can not conduct self-assessment during follow up
* difficulty in complete postoperative follow-up
* previous use of bisphosphonate/ZOL or denosumab drug
* patients have participated in similar research projects
* refused to sign informed consent
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT05595603
Study Brief:
Protocol Section:
NCT05595603